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Comparison · NCT00724815-sae

NP101 Patch vs Placebo Patch: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. NP101 Patch vs Placebo Patch: serious adverse events. Trial comparisons, record NCT00724815-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00724815-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0162wilson
Risk in group 2000.0161wilson
Risk difference, group 1 minus group 20-0.01610.0162newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1NP101 Patch
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
0234EG000
Group 2Placebo PatchThe study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.0235EG001

Harm

What it counts
Total, serious adverse events
Time frame
All Adverse Events were collected from study screening until 30 days post patch removal.

Source ClinicalTrials.gov

Trial

Title
The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
NCT number
NCT00724815
Phases
PHASE3
Conditions
Migraine Disorders
Interventions
NP101 - Sumatriptan iontophoretic transdermal patch, Placebo
Lead sponsor
NuPathe Inc.
Results first posted
2013-05-07

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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